https://medicine.ouhsc.edu/academic-departments Parent Page: Academic Departments id: 22614 Active Page: Pulmonary Clinical Trialsid:33392

PULMONARY CLINICAL TRIALS

The following clinical trials are either active and enrolling, upcoming or pending.  Contact information is also listed for patients interested in enrolling.

COPD

Titania

A Phase III, Multicenter, Randomized, Double – blind, Chronic –dosing, Parallel –group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations.  Click here for inclusion/exclusion criteria.

Principal Investigator:  Huimin Wu, MD
Core Clinical Research Staff:
Juvaria Anjum, RN
Brittany Karfonta


Pillar

A 52-week, randomized, double-blind, double-dummy, placebo- and active- controlled (Roflumilast, Daliresp® 500µg), parallel group, study to evaluate the efficacy and safety of two doses of CHF6001 DPI add-on to maintenance triple therapy in subjects with Chronic Obstructive Pulmonary Disease (COPD) and chronic bronchitis.  Click here for inclusion/exclusion criteria.

Principal Investigator:  Huimin Wu, MD
Core Clinical Research Staff:
Juvaria Anjum, RN
Brittany Karfonta

INTERSTITIAL LUNG DISEASE

ATYR 1923 C 005

Randomized, double-blind, placebo-controlled Proof-of-Conept (PoC) study to evaluate the efficacy, safety, and tolerability of efzofitimod in patients with Systemic Sclerosis (SSc)-related iterstitial Lung Disease (ILD) (SSc-ILD).  Click here for inclusion/exclusion criteria

Principal Investigator:  Jad Kebbe, MD
Core Clinical Research Staff:
Lauren Sinko, RN, BSN
Maria Mason, RN, BSN


ILD PRO

Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) and Chronic Fibrosing Interstitial Lung Disease with Progressive Phenotype Prospective Outcomes (ILD-PRO).  Click here for inclusion/exclusion criteria

Principal Investigator:  Jad Kebbe, MD
Core Clinical Research Staff:
Lauren Sinko, RN, BSN
Maria Mason, RN, BSN


Teton Study (RIN-PF-301)

Ph 3 evaluating inhaled treprostinil (Tyvaso) for the treatment of IPF, inhaled treprostinil (6 mcg/breath) administered four times daily.  Click here for inclusion/exclusion criteria

Principal Investigator:  Jad Kebbe, MD
Core Clinical Research Staff:
Lauren Sinko, RN, BSN
Maria Mason, RN, BSN


Teton RIN-PF-302

(IRB committee 11/14/22 - Board 2 - April 2023 1st rollover patient.  An open-label extension study of inhaled Treprostinal in Subjects wtih Idiopathic Pulmonary Fibrosis.  Click here for inclusion/exclusion criteria

Principal Investigator:  Jad Kebbe, MD
Core Clinical Research Staff:
Lauren Sinko, RN, BSN
Maria Mason, RN, BSN


Genentech GB44496

A two-cohort, phase II, multicenter randomized, double-blind, parallel-group, placebo-controlled study evaluating the efficacy and safety of Vixarelimab compared with placebo in patients with idiopathi pulmonary fibrosis and in patients with systemic sclerosis-associated interstitial lung.  Click here for inclusion/exclusion criteria

Principal Investigator:  Jad Kebbe, MD
Core Clinical Research Staff:
Lauren Sinko, RN, BSN
Maria Mason, RN, BSN


INSO18-055-003 (Insilico)

A phase 2a, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmaokinetics, and efficay of INSO18-066 administered orally to subjects with Idiopathic Pulmonary Fibrosis (IPF).  This study is pending.

Principal Investigator:  Jad Kebbe, MD
Core Clinical Research Staff:
Lauren Sinko, RN, BSN
Maria Mason, RN, BSN


BMS-986278

A study to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.  This study is pending.

Principal Investigator:  Jad Kebbe, MD
Core Clinical Research Staff:
Lauren Sinko, RN, BSN
Maria Mason, RN, BSN


IFE-008 (Cumberland)

A randomized, double-bline, placebo-controlled phase II study with an open-label extension to determine the safety and efficacy of oral Ifetroban in patients with Idiopathic Pulmonary Fibrosis.  This study is pending.

Principal Investigator:  Jad Kebbe, MD
Core Clinical Research Staff:
Lauren Sinko, RN, BSN
Maria Mason, RN, BSN

SAROIDOSIS

aTyr1923-C-004

A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of intravenous Ezofitimod in patients with pulmonary sarcoidosis.  Click here for inclusion/exclusion criteria

Principal Investigator:  Salim Daouk, MD
Core Clinical Research Staff:
Lauren Sinko, RN, BSN
Maria Mason, RN, BSN

ARDS

DOMPE REP01222 (RESPIRATIO)

A phase II, proof-of-concept, randomized, double-blinded, placebo controlled, multicenter study to assess efficacy of Reparixin ass add-on therapy to standard of care in adult patients with ARDS (Acute Repiratory Distress Syndrome.  Click here for inclusions/exclusions criteria

Principal Investigator:  Tony Abdo, MD
Core Clinical Research Staff:
Lauren Sinko, RN, BSN
Maria Mason, RN, BSN

PULMONARY HYPERTENSION

ROR-PH-301

A study evaluating the efficacy and safety of Ralinepag to improve treatment outcomes in PAH patient. (This study is pending.)

Principal Investigator:  Himanshu Bhardwaj, MD
Core Clinical Research Staff:
Lauren Sinko, RN, BSN
Maria Mason, RN, BSN

COUGH

CALM 1

A phase 3, 52-week, randomized, double-blind, placebo-controlled, parallel-arm efficacy and safety study with open label extension of BLU-5937 in adult partiipants with refratory chronic cough, including unexplained chronic cough.  Click here for inclusion/exclusion criteria

Principal Investigator:  Adam Przebinda, MD
Core Clinical Research Staff:
Lauren Sinko, RN, BSN
Maria Mason, RN, BSN

CATHETER-RELATED CLABSI

Mino-Lok

A Phase 3, Multi-Center, Randomized, Open-Label, Assessor-Blind Study to Evaluate the Efficacy and Safety of Mino-Lok Therapy (MLT) in Combination with Systemic Antibiotics in the Treatment of Catheter-Related or Central Line-Associated Bloodstream Infection

Principal Investigator:  Houssein Youness, MD
Core Clinical Research Staff:
Lauren Sinko, RN, BSN
Maria Mason, RN, BSN

COMMUNITY-ACQUIRED PNEUMONIA

DOMPE REP0312 (REPAVID)

Reparixin 1200 mg three times a day as add-on therapy to standard of care to limit disease progression in hospitalized adult patients with community-acquired pneumonia.  A multinational, multicenter, randomized, double-blinded, placebo-controlled, parallel-group phase III trial.  Click here for inclusion/exclusion criteria

Principal Investigator:  Houssein Youness, MD
Core Clinical Research Staff:
Lauren Sinko, RN, BSN
Maria Mason, RN, BSN


Biotest 996 ESsCAPE

A randomized, placebo-controlled, double-blind, multicenter, phase III trial to asess the efficacy and safety of Trimodulin (BT588) in adult hospitalized subjects with severe community-acquired pneumonia (sCAP).  Click here for inclusion/exclusion criteria

Principal Investigator:  Houssein Youness, MD
Core Clinical Research Staff:
Lauren Sinko, RN, BSN
Maria Mason, RN, BSN

SEPSIS

VasoActive Therapy

To evaluate the impact of the vasoactive therapy upon patients with sepsis by following routinely monitored parameters of inflammation and organ failures scores to evaluate vasoactive therapy's efficacy in mitigating the impact of sepsis on the human body.  (This study is pending.)

Principal Investigator:  Brent Brown, MD
Core Clinical Research Staff:
Lauren Sinko, RN, BSN
Maria Mason, RN, BSN